A study looking at a genetic profile to identify men at increased risk of prostate cancer (BARCODE 1 Pilot)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Prostate cancer

Status:

Closed

Phase:

Pilot

This study is for white Caucasian men aged between 55 and 69 years old who have not had prostate cancer.

More about this trial

A man’s risk of developing prostate cancer is increased if they have certain gene changes or faulty genes. Researchers are interested in gene changes that can increase or decrease a man’s risk, each by a small amount.

The researchers of this study have developed a genetic profile. They want to test it in men who have not had prostate cancer.

The study team will look at saliva samples to study the DNA. They will look for some of these common changes. Each change is given a score and the scores are added up to give an overall risk of developing prostate cancer. This is called a genetic risk score.

In this study those men who have a higher genetic risk score are offered an appointment with a doctor to discuss the option of prostate cancer tests. The researchers will follow these men thought to be at high risk and record test results, any diagnosis of prostate cancer and treatment.

The aim of this study is to find out if the genetic profile identifies those men at an increased risk of prostate cancer.

Depending on the results of this study the team might also be able to develop a screening programme for men who are at a higher risk of developing prostate cancer.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

You may be able to join this study if you have been invited to take part by your GP surgery and all of the following apply. You

You are from an ethnic group other than white Caucasian, you cannot take part if you are Jewish or mixed race

You have prostate cancer, or have had prostate cancer in the past

You have another type of cancer that cannot be cured and is expected to limit your life expectancy

You have had a biopsy of your prostate cancer in the last year

Your doctor advises against you having a prostate biopsy because of another medical condition. For example you are taking medicine such as warfarin to prevent blood clots, or you have diabetes which is difficult to control or you have certain heart conditions such as uncontrolled angina or severe heart failure

Why is this study only recruiting white Caucasian men?
The genetic profile in this study has been developed as a result of studies looking at white Caucasian men.

People of different ethnic backgrounds have differences in their genetic makeup. So using this genetic profile in men who are not white and Caucasian could give an inaccurate genetic score.

Trial design

GP practices are sending out letters to eligible men, asking them to take part. If you receive a letter and would like to take part you can

fill out the questionnaire and send it back in the post

complete the questionnaire online via the study website

The study team may telephone you if they need to clarify any information in your questionnaire.

If you are eligible, you receive a kit in the post, to collect a sample of your saliva. The study team then use a sample to work out your genetic risk score. They identify those men who fall into the top 10% of the genetic scoring system. This means that for every 100 men, the 10 men who have the highest score fall into this category.

It is important to remember that this is a research study. If your score falls into the top 10%, it does not definitely mean that you have an increased risk of developing prostate cancer. This is what the study is trying to find out.

Also, the genetic profile does not take into account a man’s family history. If your father or brother have, or have had prostate cancer, you may be at an increased risk. This is regardless of what your score is in this study. If you have a family history of prostate cancer, do talk to your GP about this.

If you are not in the top 10%
You will receive a letter explaining these results.

The study team would like to collect information about your health and any changes over the next 5 years. You don’t need to see anyone from the study team. They will do this by looking at your medical records and the cancer registries.

A high genetic risk scoreYou are offered an appointment with the study team. This takes place at the Royal Marsden Hospital in London.

Appointment 1
The doctor explains what your genetic score means and will talk about taking a sample (biopsy) of your prostate gland. The doctor will discuss the pros and cons of a prostate biopsy. This appointment will take about an hour.

You do not have to make a decision straight away. You can go away and think about it. And discuss it further with your GP and friends and family if you want to.

If you decide not to have the biopsy, you have no further appointments as part of this study.

If you decide to have the biopsy, you have at least 3 further appointments.

Appointment 2
You have blood tests and provide a urine sample. One of the blood tests is to measure the level of a protein called prostate specific antigen (PSA). The PSA blood test is high in some men with prostate cancer. But it can also be raised in other prostate conditions.

The doctor needs to examine your prostate gland. They do this by putting a gloved finger into your back passage. This is called a digital rectal examination. You provide a urine sample before and after this examination.

Your blood and urine samples are also used for a number of different tests. For example, the study team will look at particular substances, such as proteins and hormones. This will hopefully help them understand how these play a part in the development of prostate cancer.

You might have your first and second appointments on the same day. This may happen if you are certain that you want to have a prostate gland biopsy.

You might also have an MRI scan of your prostate gland. The researchers then compare the results of this scan with the biopsy. This will be an extra hospital appointment.

Appointment 3
You have your prostate gland biopsy. The doctor puts a small ultrasound device into your back passage (rectum). The ultrasound image helps the doctor to guide a needle through the wall of the rectum. They then take several tissue samples of the prostate gland.

The biopsy takes about 45 minutes.

The researchers ask for 2 extra samples of prostate gland tissue when you have your biopsy. These will be stored for future research. If you don’t want to give these samples for research, you don’t have to. You can still take part in the study.

Appointment 4
You go to hospital to get the results of your prostate gland biopsy.

If you have prostate cancer, the doctor will explain the different treatment options and the side effects of these treatments.

Making a decision whether to have treatment can be difficult. The study doctor will make sure you have the opportunity to ask questions and give you time to think about this.

If your biopsy is normal and does not show any cancer, you have regular PSA blood tests. You have them every 6 months for 5 years. The study team might recommend that you continue these tests with your GP. This depends on your previous test results.

The study team would like to continue to collect information about all men who had a prostate biopsy as part of this study. They will record any changes in health for about 5 years by looking at your medical records.

Hospital visits

If you do not have a high genetic risk score, you don’t have any hospital appointments at part of this study.

If you have a higher genetic risk score and choose to have tests, you have at least 3 or 4 appointments.

Side effects

The side effects of a prostate biopsy include

Pain or discomfort

Bleeding

Infection

You start a short course of antibiotics just before your biopsy to reduce the risk of infection. Drink plenty of water (about 6 to 8 glasses) in the 24 hours following your biopsy.

It is normal to have some blood in your urine for at least 2 or 3 days and this may last for about 2 weeks. You may see blood in your semen for between 8 to 12 weeks. And you may also notice some blood coming from your back passage (rectum) for about 1 or 2 days.

Contact the study team or your GP if the bleeding lasts for longer. Or it is getting worse.

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